QT ECG - PCA-A200 Electrode Cable is intended to be used - QT MEDICAL, INC.

Duns Number:078875059

Device Description: PCA-A200 Electrode Cable is intended to be used with ECG devices. The Electrode Cable is u PCA-A200 Electrode Cable is intended to be used with ECG devices. The Electrode Cable is used to connect electrodes of QT Medical, Inc. placed at appropriate sites on the patient to the Monitor/Defibrillator for general monitoring and/or diagnostic evaluation by healthcare professionals.

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More Product Details

Catalog Number

-

Brand Name

QT ECG

Version/Model Number

PCA-A200

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

IKD

Product Code Name

Cable, Electrode

Device Record Status

Public Device Record Key

6aa6335d-de6f-4a4c-ac27-da45f218cfc8

Public Version Date

July 12, 2021

Public Version Number

1

DI Record Publish Date

July 02, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"QT MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 18